A Phase I Trial of the Dual Kinase Inhibitor GW572016 in Combination With Topotecan in Patients With Advanced Solid Malignancies

Trial Information

A Phase I Trial of the Dual Kinase Inhibitor GW572016 in Combination With Topotecan in Patients With Advanced Solid Malignancies

Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and
will be given Topotecan intravenously on Days 1, 8 and 15. During Cycle 1 participants will
be required to spend the evening before Day 1 in the General Clinical Research Center and
frequent blood samples will be drawn on Day 1; this schedule will be repeated the evening of
Day 6 with the blood samples drawn on Day 7. Participants will have weekly CBCs.

Inclusion Criteria

Age 18 and older Histologic proof of cancer that is unresectable ANC greater than 1500 u/L
PLC greater than 100,000 u/L Total bilirubin less then or equal to ULN AST less than 3 x
ULN or AST less than 5 x ULN if liver involvement Creatinine less than 1.5 x ULN
Hemoglobin greater than 9 g/dL Echocardiogram with ejection fraction great than 40% Life
expectancy of more than 12 weeks

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